Kornimate/medical-research-clean huggingface dataset:
beetroot enriched bread, blood pressure and vascular function

Conditions: Hypertension

Summary: dietary nitrate is known to lower blood pressure. beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. we evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.


Eligibility criteria:
inclusion criteria: * male * a signed consent form * age 18-64 years * body mass index - 18.5-30 kg/m2 * non-smoking, healthy individuals * normal blood pressure at screening (\< 150/90) exclusion criteria: * subjects with anaemia * sufferers of chronic illnesses * individuals with food allergies * people with diabetes * people with coeliac disease * women * vegetarians

Keywords: beetroot blood pressure vascular function
identification of multiple pulmonary diseases using volatile organic compounds biomarkers in human exhaled breath

Conditions: Lung Cancer; Lung Infection; COPD; Bronchitis; Pulmonary Fibrosis; Pulmonary Embolism; Pulmonary Arterial Hypertension; Pulmonary Tuberculosis; Pulmonary Abscess; Emphysema; Lung Injury; Cystic Fibrosis of the Lung; Bronchial Asthma; Bronchiectasis; Interstitial Lung Disease; Preserved Ratio Impaired Spirometry

Summary: the goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (voc) marker molecules. this model aims to accurately diagnose mutiple pulmonary diseases. the primary objectives it strives to accomplish are: 1. to assess the diagnostic accuracy of an exhaled breath voc-assisted diagnostic artificial intelligence (ai) model in diagnose several common pulmonary diseases. 2. to assess the diagnostic accuracy of an exhaled breath voc-assisted diagnostic artificial intelligence (ai) model in diagnose more pulmonary diseases.

this is a prospective, cross-sectional, observational cohort study aimed at recruiting 10,000 participants with multiple pulmonary disease, including lung cancer, lung infection, chronic obstructive pulmonary disease (copd), bronchitis, pulmonary fibrosis, pulmonary embolism, pulmonary arterial hypertension, tuberculosis, lung abscess, emphysema, radioactive lung injury, cystic fibrosis of the lung, bronchial asthma, bronchiectasis, interstitial lung disease (ild), preserved ratio impaired spirometry (prism) etc . exhaled breath samples from these participants will be collected and analyzed using gas chromatography-mass spectrometry(gc-ms) and micro gas chromatography-photoionisation detector (μgc-pid) system. upon obtaining the μgc-pid results, a comprehensive evaluation of the diagnostic capabilities of exhaled breath samples in differentiating various pulmonary diseases will be performed, leveraging clinical diagnostic results, ct examination data, and clinical data.

Eligibility criteria:
inclusion criteria: * males or females, age must be 18 years old or above. * patients must meet the ct imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of ct image data. * patients must have a clear clinical diagnosis. * all participants must sign a written informed consent form. exclusion criteria: * pregnant women. * individuals with a history of cancer other than lung disease. * individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants. * individuals with other severe organic diseases or mental illnesses. * individuals with metabolic diseases such as diabetes, hyperlipidemia, etc. * any other condition that researchers deem unsuitable for participation in this clinical trial.

Keywords: pulmonary disease volatile organic compounds human exhaled breath micro gas chromatography-photoionisation detector (μgc-pid) system
patient voices integration of systematic assessment of patient reported outcomes within clinical oncology practice

Conditions: Neoplasms; Symptoms and Signs; Psychological Distress; Satisfaction, Consumer; Quality of Life

Summary: listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. it is in fact crucial in medical decision making and patient empowerment, especially in cancer care. patient reported outcomes measures (proms) and in particular electronically assessed proms (eproms), have been identified as potentially effective tools to systematically gather patient voices. despite international extensive and growing interest, systematic prom collection is not widely implemented in routine cancer care, due to barriers at various levels. the patient voices is a project aimed at achieving a stepwise inclusion and integration of proms within routine clinical practice at the fondazione irccs istituto nazionale tumori-milano. phase i of the patient voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).

study aims of this phase are: * assessing the use and attitudes toward proms by clinicians in a comprehensive cancer centre. * reviewing and compare pre-existing eproms assessment systems. * developing and pilot testing a flexible system for electronic collection of proms. * assessing feasibility of eprom assessment of physical symptoms, psychological distress and patient satisfaction. * identifying barriers to and developing strategies for the final implementation and integration of routine eproms into the clinical practice. the project will last 2 years. longitudinal and cross-sectional studies will be carried out with the aim to evaluate compliance, acceptability, and usability of a routine eprom assessment system by both patients and clinicians. participants will be enrolled among patients attending 3 out-patient clinics (physical symptom), 3 inpatient wards (psychological distress) and 5 multidisciplinary teams (patient satisfaction). the edmonton symptom assessment scale, the distress thermometer, and a questionnaire adapted from the bench-can and euracan projects plus the institutional customer satisfaction survey, will be used in the three studies. qualitative methods will be used identify patient and clinician related barriers to eprom assessment and to pinpoint engagement strategies to promote its use in routine cancer care. semi-structured interviews and focus groups will be carried out. quantitative and qualitative studies will respectively enroll 600 and 40 participants.

Eligibility criteria:
inclusion criteria: * age 18 years or above * a verified cancer diagnosis exclusion criteria: * inability to fill in proms due to cognitive impairment, psychological disturbance or language problems as judged by the study personnel.

Keywords: patient reported outcome measures feasibility study
comparison of the efficacy and safety of ivermectin to permethrin

Conditions: Scabies

Summary: comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

administration of ivermectin or permethrin on day0 clinical examination and pictures on day0, day14 and day28 blood sample on day0 vas for pruritus, dlqi and sf-36 on day0, day14 and day28

Eligibility criteria:
inclusion criteria: at least one of the following inclusion criteria: * scabies tunnels * positive microscopic examination (acarids, faeces or ova) at least two of the three following inclusion criteria: * non-specific injuries with a typical distribution pattern * serious itching which increases during the night * family or contacts with similar complaints exclusion criteria: * treatment for scabies \< 4 weeks ago * treatment with corticoids \< 1 week ago * pregnancy * breast-feeding * hiv * serious immunodepressive patients * sensitivity or allergy to one of the components of the study medication * damage of the central nerve system
elective abdominal aortic aneurism - open versus endovascular repair

Conditions: Elective Abdominal Aortic Aneurysm

Summary: abdominal aortic aneurysm (aaa) is a life threatening disease. there is a consensus to propose surgical repair in patients with a reasonable operative risk when the aaa exceeds 5 cm in diameter. the aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by evar (endovascular aneurysm repair). the main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

ace trial :not worn-out aneurism of the abdominal aorta under renal " surgery versus endoprosthesis abdominal aortic aneurysm (aaa) is a life threatening disease. there is a consensus to propose surgical repair in patients with a reasonable operative risk when the aaa exceeds 5 cm in diameter. the aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by evar (endovascular aneurysm repair). the main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

Eligibility criteria:
inclusion criteria: * patients aged 50 years old or more (more than 80 possible depending on physiological age) * level 0, 1, or 2 of operative risk * abdominal aortic aneurysm with a diameter \> or equal to 50 mm or \> or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm; * aortic neck superior or equal to 1.5 cm * no stenosis superior or equal to 75% of the superior mesenteric artery * proximal neck angulation inferior to 80° * diameter of the iliac arteries compatible with introducer sheath * inform consent signed exclusion criteria: * aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm * thrombus or major calcification in the neck * diameter of the iliac arteries not compatible with introducer sheath * level 3 of operative risk * history of major iodine allergy (quincke oedema, anaphylactic shock) * other comorbidity with life expectancy less than 6 months * follow up impossible during the trial * participation in another trial * inform consent not signed

Keywords: abdominal aortic aneurysm endograft open repair endovascular repair aaa
clinical- and immunological activity, safety and tolerability of different doses / formulations of affitope ad02 in early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early alzheimer's disease in male and female patients aged 50 to 80 years. approximately 40 study sites in europe will be involved. patients will be randomized to receive either affitope ad02 or placebo. each patient's participation will last 1 year.

affitope ad02 is a second generation ad immunotherapeutics targeting aβ. its active component is a synthetic peptide functionally mimicking the unmodified n-terminus of aβ.

Eligibility criteria:
inclusion criteria: * informed consent capability * early ad, based on episodic memory deficit and hippocampal atrophy * age from 50 to 80, inclusive * mmse of 20+ * brain magnetic resonance imaging scan consistent with the diagnosis of ad * stable doses of medications (cholinesterase inhibitors and memantine allowed) * caregiver able to attend all visits with patient exclusion criteria: * significant neurological disease other than ad * major psychiatric illness * significant systemic illness * autoimmune disease * prior treatment with experimental immunotherapeutics for ad including ivig * women of childbearing potential without birth control * contraindication for mri scan
clinical trial to assess influence of mycyfapp use on gi related qol in children with cystic fibrosis

Conditions: Cystic Fibrosis in Children

Summary: interventional trial to study the influence of the use of mycyfapp (mobile application) on the gastro-intestinal related quality of life. this mobile app has been developed during previous workpackages of the horizon2020 project and contains several modules: * mathematical prediction model to calculate the needed dose for pancreatic enzyme replacement therapy * educational games and other educational material * communication with doctor/dietician through professional webtool * diary to register symptoms and data on nutrition. the app will be introduced and used during 6 months. primary outcome parameter will be change in modified pedsql gi after 3 months. pedsql gi is an existing questionnaire that evaluates gastro-intestinal related quality of life in children. we validated it for use in cystic fibrosis in a previous observational study.


Eligibility criteria:
inclusion criteria: 1. diagnosis of cf as evidenced by one or more clinical feature consistent with the cf phenotype or positive cf newborn screen and one or more of the following criteria: 1. a documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis (qpit) 2. a documented genotype with two disease-causing mutations in the cftr gene 2. having pancreatic insufficiency (stool elastase \< 200 mcg/g stool) and using pert 3. age ≥ 24 months and \< 18 years at screening visit 4. informed consent by parent or legal guardian; assent for children from age 12 years on 6. inclusion visit coincides with scheduled routine clinic visit 7. ability and willingness to comply with app use and evaluations at time of routine clinic visits as judged by the site investigator 8. availability of wifi connection at home so that connection to the internet is feasible at home at least weekly. exclusion criteria: 1. acute infection associated with decreased appetite or fever at time of run-in visit 2. acute abdominal pain necessitating an intervention at time of run-in visit 3. physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator 4. investigational drug use within 30 days prior to run-in visit 5. started with cftr modulator treatment less than 3 months before start of run-in visit 6. inability to use the app due to patient specific factors such as language or learning difficulties

Keywords: pert mobile application
phase 1b/2 study of futibatinib in combination with binimetinib in patients with advanced kras mutant cancer

Conditions: Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations; Non-Small Cell Lung Cancer; KRAS Gene Mutation

Summary: phase 1b/2 study to evaluate the fgfri futibatinib in combination with the meki binimetinib in patients with advanced krasmt tumors.

this is an open-label, nonrandomized, uncontrolled phase 1b/2 study to determine the recommended phase 2 dose (rp2d) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced krasmt tumors. the study will consist of two parts: * part 1: dose-escalation part to determine the rp2d and dosing schedule of futibatinib in combination with binimetinib in patients with advanced cancer disease * part 2: dose-expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the rp2d in patients with advanced krasmt nsclc patients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met. no patients were enrolled in phase 2 as the sponsor decided to not proceed with the dose expansion phase 2 part of the tas-120-204 study.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced cancer of any tumor type (part 1) or nsclc with a confirmed kras mutation as determined by local results (part 2) * appropriate candidate for experimental therapy * for patients in part 2 only: patient has radiographically measurable disease per recist 1.1 criteria. * eastern cooperative oncology group (ecog) performance status 0 or 1. * adequate cardiac function (left ventricular ejection fraction (lvef) ≥50% ) * adequate organ function * must have tumor tissue specimen available (optional for patients in part 1) exclusion criteria: * history or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues * current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. * known untreated central nervous system (cns) metastases or history of uncontrolled seizures. * significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib * patients who have neuromuscular disorders that are associated with elevated creatinine kinase (ck)

Keywords: futibatinib binimetinib meki fgfr fgfri tas-120 krasmt nsclc
evaluation of a conservative treatment by nocturnal wrist orthosis in the non-surgical management of carpal tunnel syndrome (amylyoncarp)

Conditions: Carpal Tunnel Syndrome

Summary: this study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other. it will also be possible to assess their comfort and compliance as well as the impact of wearing them on neurological and muscular recovery (functional assessment).

after selection of patients suffering from carpal tunnel syndrome during consultation visits, the study will be explained to them, an information sheet and a consent form will be given to them. a subgroup of patients who have undergone a diagnostic electromyogram at the study center (defined as a functional assessment subgroup) will be randomized independently of the other participants (2 randomization lists will be generated). the randomization will be done on 2 groups: one benefiting from a wrist orthosis called simple rest, and the other from a wrist-hand-finger orthosis called global rest. an appointment for making the orthosis will be fixed with the manufacturer within one month of inclusion. the follow-up will then be done by 2 telephone collection visits at 1 month then at 2 months of the implementation of the device then by a last visit at 3 months consisting in a consultation for the functional assessment subgroup and a phone call for the others.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with unilateral or bilateral, idiopathic or secondary carpal tunnel syndrome, without surgical indication (emg with myelin sensory signs without axonal involvement) * signed consent * affiliation to social security exclusion criteria: * patients with carpal tunnel syndrome with severity criteria * patient refusal * patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment * presence of skin lesion in the area of the orthosis * current participation in another research protocol involving the human person
correlation between quantitative analysis of coronary mra and ffr

Conditions: Coronary Artery Disease; Magnetic Resonance Angiography; Fractional Flow Reserve

Summary: this study aims to evaluate whether quantitative analysis of coronary mr angiogram would improve the detection of functionally-significant coronary artery stenosis.

coronary mr angiography is performed with a 3.0-t imager with 32-channel coils. qunatitative analysis of coronary mr angiogram is evaluated on the basis of the signal intensity (si) profile along the vessel. quantitative analysis of coronary mr angiogram (qcmra) is calculated as \[1 - (simin/siref)\] x 100, where simin is minimal si and siref is corresponding reference si. diagnostic performance of quantitative analysis of coronary mr angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (ffr) as the reference standard.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary mr angiogram * patient who were planned to undergo invasive coronary angiography and fractional flow reserve exclusion criteria: * clinically unstable patient * a history of coronary revascularization * infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis * contraindication to use of adenosine * complete occlusion of target lesion
epidemiology of injuries in the professional women's swedish national icehockey league permitted to body-checking

Conditions: Sport Injury; Ice-Skates Accident; Sports Accident; Female Athlete Triad; Female

Summary: this research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. an understanding of common injury types and mechanisms aids the clinician in diagnosis and management. this information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. reducing the number and severity of sport-related injuries is therefore of importance. knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. currently, only a minority of all sports medicine research is made on female study participants (26). this research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions.


Eligibility criteria:
inclusion criteria: * minimum 16 years of age, registered player in the highest swedish professional ice hockey league for women, sdhl exclusion criteria: * age under 16 years.

Keywords: women's health ice hockey elite sport injuries bodychecking